ICU Nutrition Study Bern
Primary Purpose
Critical Illness, Starvation, Enteral Nutrition
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Data Collection
Nutritional management protocol
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring Critical care, Intensive care unit, Early enteral nutrition, Nutritional management protocol
Eligibility Criteria
Exclusion Criteria:
- <18 years of age
- stay less than 72 hours on ICU
- die within 72h after admission
- patients admitted for palliative care
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Observation
Nutritional management protocol
Arm Description
Observation
Collection of patient data after implementation of a nutritional management protocol
Outcomes
Primary Outcome Measures
Energy delivered (%of caloric target) before and after introducing the nutritional management protocol.
Protein delivered (% of caloric target) before and after introducing the nutritional management protocol
Start of enteral feeding after ICU admission
Secondary Outcome Measures
ICU mortality
Hospital mortality
length of ICU stay
length of hospital stay
use of antibiotics (days)
rate of accurately defined infections
Full Information
NCT ID
NCT00574431
First Posted
December 14, 2007
Last Updated
July 13, 2015
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Abbott Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT00574431
Brief Title
ICU Nutrition Study Bern
Official Title
Implementation of an Evidence-based Nutritional Management Protocol in Critically Ill Patients:Does Clinical Outcome Improve?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Abbott Nutrition
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Nutritional treatment has become an essential component of the management of critically ill, due to better knowledge about positive impact of nutritional support. Malnutrition among ICU patients is associated with increased morbidity, mortality, length of stay (LOS) and therefore higher costs.Several studies however suggest, that early implementation of nutritional support is associated with improved clinical outcome, shorter LOS, and decreased infection rates. One of the objectives of this study is to determine if an nutrition protocol can improve the delivery of enteral tube feeding in the ICU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Starvation, Enteral Nutrition
Keywords
Critical care, Intensive care unit, Early enteral nutrition, Nutritional management protocol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observation
Arm Type
Other
Arm Description
Observation
Arm Title
Nutritional management protocol
Arm Type
Active Comparator
Arm Description
Collection of patient data after implementation of a nutritional management protocol
Intervention Type
Other
Intervention Name(s)
Data Collection
Intervention Description
Collection of patient data before implementation of a nutritional management protocol
Intervention Type
Other
Intervention Name(s)
Nutritional management protocol
Intervention Description
Collection of patient data after implementation of a nutritional management protocol
Primary Outcome Measure Information:
Title
Energy delivered (%of caloric target) before and after introducing the nutritional management protocol.
Time Frame
During ICU stay
Title
Protein delivered (% of caloric target) before and after introducing the nutritional management protocol
Time Frame
During ICU stay
Title
Start of enteral feeding after ICU admission
Time Frame
During ICU stay
Secondary Outcome Measure Information:
Title
ICU mortality
Time Frame
During ICU stay
Title
Hospital mortality
Time Frame
During hospital stay
Title
length of ICU stay
Time Frame
During ICU stay
Title
length of hospital stay
Time Frame
During hospital stay
Title
use of antibiotics (days)
Time Frame
During ICU stay
Title
rate of accurately defined infections
Time Frame
During ICU stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Exclusion Criteria:
<18 years of age
stay less than 72 hours on ICU
die within 72h after admission
patients admitted for palliative care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Leuenberger, MD
Organizational Affiliation
University hospital of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephan M Jakob, MD, PHD
Organizational Affiliation
University hospital of Bern
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zeno Stanga, MD
Organizational Affiliation
University hospital of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margaret Schafer, MD
Organizational Affiliation
University hospital of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jukka Takala, MD, PHD
Organizational Affiliation
University hospital of Bern
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
ICU Nutrition Study Bern
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